System & Processes Sw

apan B

andyopadhyay

Data is the proof of evidence that we did it

as per guidelines and submitted-filings.

Data integrity must be maintained

across the entire process of business.

data is generated out of;

People

Processes

Computerized systems

Communications

What is “DATA” B

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Why “Data Integrity” ?

• To have evidence that the work has been done in the

manner as has been stated in the SOP/ Dossier / DMF.

• To get back the right data when needed for analysis.

• To save losses from Business due to data fraud.

• To establish the right work culture at work stations.

• Spent money is utilized the way it was Designed in the

approved processes.

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“Data Integrity” - Challenges

Data Integrity

Inadequate procedures in

SOPs.

Poor Training System / Employee

Engagement

Invalidated & uncontrolled

software systems

Improper equipment

procurement due to lack of

knowledge

Fraudulent intensions / following shortcuts/

Business Pressure

No system or poor system of Data checks &

Data Audit

Organization's action Organization's action

Organization's action Employee's action

Org

aniz

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cti

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Em

plo

yee's a

cti

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Em

plo

yee's a

ctio

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plo

yee's a

ctio

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“Data Integrity” – Assessment & CAPA

• New Assessment system

• Risk Based Approach

• Preventive Measures

• Intermittent Audits

• Data management system Development

• Evaluation of new equipment for data integrity system

• Audit , FAT & PAT based on Data Integrity system

• New SOPs, Documents describing Data Integrity system

• Modified Chang control approval process.

• Analysis on existing methods

• Market data assessment

• Review of failures

• Complaint Management system review

• CAPA system review

• Investigation system review

• Analysis System review

• Data Management System Audit

• Evaluation of Current Processes

• Training of Personnel

• Management focus

• Survey of data Fraud Linkages

• Organization’s Aim assessment

Current status Checks

Current status Checks

Risk Evaluation

Risk Evaluation

Designing CAPA Actions

Designing CAPA Actions

Continuous Improvement

Actions

Continuous Improvement

Actions

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“Data Integrity” – Management Supports M

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Boosting Of Employees Morale & Motivations

Boosting Of Employees Morale & Motivations

Audit by External / Internal Agency

Audit by External / Internal Agency

Focus on System Development &

Making a Part of MIS

Focus on System Development &

Making a Part of MIS

Necessary Investment

&

Administrative Actions

Necessary Investment

&

Administrative Actions

“Data Integrity” – Employees’ Contributions E

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Employees &

Data Integrity

System

Act the way of SOP

Be Ethical

&

Report Issues

Prevent Fraud by reporting

cases

Learn the Process

Be In System Be Open

Be Innovative Be In Policies

“Data Integrity” – Vendors management V

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Training for the Data importance &

Data Management at their Place

Making agreement incorporating data transparency & integrity

requirements.

Vendor Audits & rewarding good vendors by means of increased price or any other ethical means. Involving

good vendors in the organization’s celebration of events

“Data Integrity” – Customers Education C

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Take part in Customer’s satisfaction

survey

Listen to Customers Visit Customer’s Place and guide

them

Sharing Knowledge

&

Issues

Support

Customers in learning

Training by calling them in-

house

Support them with system

requirements

Design Actions for Your Organization

Obtain Regular feed back

“Data Integrity” – System Requirements C

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* Fraud Control

mechanism

* Mistake Proof

Systems

* Password protection

* Training & Evaluation

Data Acquisition systems on hardware

Data safe Software

(Tamper Proof)

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Thanks